Kornimate/medical-research-clean huggingface dataset:
autonomic assessment in patients with restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: restless legs syndrome (rls) is a sensorimotor, sleep-related disorder characterized by urgency to move the legs during inactivity or resting state. although the exact mechanism is not clearly understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction. the objective of the study is to evaluate autonomic functions and determine possible associations between autonomic dysfunction with clinical factors in patients with rls.

restless legs syndrome (rls) also known as willis- ekbom disease, is a common sensorimotor, sleep-related disorder characterized by an unpleasant feeling with urgency to move the legs (or less commonly the arms) during inactivity or resting state. although, the clinical importance of autonomic involvement in patients with restless legs syndrome (rls) remains incompletely understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction. previous reports have described autonomic impairment including changes in nocturnal blood pressure and heart rate variability (hrv), gastrointestinal, urinary and sexual dysfunction in patients with rls. despite many studies about electrophysiological autonomic changes in rls, number of studies exploring autonomic functions by using scales for outcomes in parkinson's disease-autonomic questionnaire (scopa-aut) are limited. in this study, the investigators plan to compare the presence of autonomic symptoms by using scales for outcomes in parkinson's disease-autonomic (scopa-aut) questionnaire in drug- naive rls patients to healthy controls. in addition, the investigators aim to evaluate possible associations between autonomic dysfunction with clinical factors in patients with rls.

Eligibility criteria:
inclusion criteria: for the patient group: * age \>18, \<65 * newly diagnosed, drug naive patients with primary restless legs syndrome for the control group: * age \>18, \<65 * participants without chronic systemic disorder exclusion criteria: * previous diagnosis of primary rls * subjects with secondary rls * concomitant use of drugs that could interfere with autonomic nervous system * individuals with a known acute/chronic medical disease * individuals with a minimental test score \< 25/30 * sleep disorders that could affect test performances

Keywords: restless legs syndrome autonomic dysfunction dysautonomia scopa-aut questionnaire
fibromyalgia and specific physical activity

Conditions: Fibromyalgia

Summary: fibromyalgia is a common, expensive and controversial condition, one of whose origins would be central nervous system sensitization to pain. usual treatment consists of multimodal care including physical activity. this dosage should be adapted to the patient's health needs. currently recommended physical exercise is aerobic work associated with muscle reinforcement, without evidence of superiority of the efficacy of one over the other. recommended dosage for aerobic exercises is 20 minutes (or twice 10 minutes), two to three times a week (70 - 80% of theoretical maximum heart rate). at the vendee departmental hospital center (chd), adapted physical activity is proposed to fibromyalgia patientsby the associative group "siel bleu". this physical activity, performed with patients suffering from different pathologies, is non specific for fibromyalgia context. in parallel, a preliminary study showed the interest of a lifestyle coaching for fibromyalgia patients, performed by physiotherapists, nurses and coaches specifically trainede. another possibility seems to be personalized coaching with a physical activity adapted to the physical and organizational constraints of the patient, and specific to pathology. this solution would make it possible to adapt to the patient's choice of physical activities, to ensure a better adaptation to their physical and organizational constraints as well as a better individualized follow-up.


Eligibility criteria:
inclusion criteria: * major patient * patient whose fiq ≤ 59/100 * patient who can be followed for 12 months in the cetd * patient able to follow the adaptated physical activities proposed by "siel bleu", on the physical and organizational level * patient with a smartphone and/or a computer (mac/pc) with an internet connection allowing the use of a tracking application linked to the activity tracker * patient with the ability to understand protocol and consenting to participate in this study * patient benefiting from a social cover exclusion criteria: * patient participating in an interventional trial within 3 months of enrollment * pregnant or lactating woman, or having the possibility to procreate without effective contraception * patient minor, under guardianship, curators or deprived of liberty * patient unable to follow the protocol, according to the judgment of the investigator, or refusing to use of digital applications * patient with contraindications to physical activity * patient having already followed the physical activities proposed by 'siel bleu"
angiogenic switch in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: a group of colorectal cancer (crc) patients treated with chemotherapy and bevacizumab (bev) maintain the same sensitivity after progression to maintenance treatment because they remain dependent on vegf angiogenic mediator, while other patients in whom there is an angiogenic switch (as) become dependent on other angiogenic cytokines and become resistant to bev chemotherapy combinations .


Eligibility criteria:
inclusion criteria: * diagnosis of stage iv colorectal adenocarcinoma. * age ≥ 18 years . * measurable disease by recist criteria. * life expectancy ≥ 6 months. * candidate to receive treatment with first-line chemotherapy. * availability of tumor tissue. exclusion criteria: * patients who have received prior treatment with first-line chemotherapy for metastatic disease. * patients in whom there is contraindication to the administration of either drug used in the study: capecitabine, irinotecan, oxaliplatin or bev. * patients receiving anticoagulant oral treatment. * patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · the inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually * patients with bone disease as the only manifestation of the disease.

Keywords: angiogenic switch plasma cytokines colon cancer
intraoperative methadone in children undergoing surgery

Conditions: Pain, Acute; Pain, Postoperative; Children, Only

Summary: a prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.

treatment of postoperative pain is a challenge in younger children undergoing outpatient surgery. after discharge parents must assess pain intensity and administer analgesics, including opioids, as per needed. it has been shown that parents often hesitate to administer analgesics. the result is unrelieved pain that negatively affects the whole family and increases the risk of unscheduled contacts with healthcare professionals. in children, methadone has shown a half-life of 19,2 +/-13,6 hours. regarding outpatient surgery, methadone is an opioid with unique pharmalogical properties that may be advantageous. a single-dose of this long acting opioid administered perioperatively could provide a stable analgesia and potentially reduce the need for shorter-acting opioids in the pacu and at home.

Eligibility criteria:
inclusion criteria: children scheduled for open urological surgery at the outpatient clinic at aarhus university hospital. exclusion criteria: * age =/\> 5 years at the date of operation * born preterm (before gestational age of 37 weeks) * congenital heart disease * previous scrotal surgery * laparoscopic operation * american society of anaesthesiologists (asa) physical status lll, iv or v * allergy to study drugs * preoperative daily use of opioids * parents with inability to provide informed consent * severe respiratory insufficiency * acute abdominal pain * severe kidney insufficiency * treatment with rifampicin

Keywords: methadone analgesics opioids postoperative placebo
art therapy to address hospital clinician burnout

Conditions: Burnout; Anxiety; Stress; Depression

Summary: a structured group art therapy intervention, comprising six 60 - 90-minute weekly workshops.

the chart group art therapy intervention builds on a 6-week art therapy group intervention piloted with barts health oncology and palliative care doctors (tjasink, m. 2019). it incorporates elements of workshops delivered for staff support by barts art therapists during the covid-19 pandemic (tjasink, m., stevens, p. 2022). the intervention is broadly informed by affective neuroscience and evolutionary psychology theories with an emphasis on compassion-focused and resource-oriented therapeutic practice. whilst the intervention draws on diverse influences, it aligns with the principles of compassion focussed therapy (cft), an integrative, bio-physiological psychological model underpinned by evolutionary theory. intervention elements include psycho-education, individual art making, collaborative group art making, art making in pairs, exploring a range of art materials and techniques (including clay, paint, natural objects and non-traditional mark - making materials), art-based grounding exercises and reflective discussion. the intervention manual was developed by the study's chief investigator with input from a group of three art therapy experts (health and care professions council (hcpc) accredited art therapists working in national health service (nhs) medical contexts with experience of delivering art therapy - based staff support) and three experts by experience (health care professionals with experience of participating in art therapy - based staff support groups at work). adherence to the intervention will be monitored through two adherence tools (therapist self reported and independent observer).

Eligibility criteria:
inclusion criteria: * • healthcare professional employed in a patient facing clinical role by barts health nhs trust or barts bank partners * 18 years or older * willing and able to provide informed consent * able to attend the group intervention sessions * moderate to severe risk scored on any of the three mbi - hss subscales or on the pss 10: * emotional exhaustion score of ≥17, or * depersonalization score of ≥7, or * personal accomplishment score of ≤ 38 or * perceived stress (≥ 14) exclusion criteria: * • unwilling or unable to give consent * diagnosed with or treated for a serious depressive condition, a personality disorder or psychosis in the past 12 months. (self-reporting through screening.) * attempted suicide or made plans to commit suicide in the past 12 months. (self-reporting through screening.) * individual does not provide direct patient care for barts health nhs trust

Keywords: art therapy psychosocial distress hospital clinicians burnout
screening women for functional hypothalamic amenorrhea (fha)

Conditions: Amenorrhea Secondary

Summary: what do the investigators know already? many women suffer loss of periods (amenorrhoea). one of the most common causes of period loss is called 'functional hypothalamic amenorrhea' (fha). fha is difficult to diagnose and may be mistaken for other conditions causing period loss, such as polycystic ovarian syndrome (pcos). this could cause delays in starting the correct treatment. what is the justification for doing this study? undiagnosed women with fha are predisposed to complications related to low oestrogen levels, such as osteoporosis, bone fractures and infertility. the failure to accurately identify women with fha and mislabel those women with fha as having pcos, may delay appropriate treatment. treatment delay causes harm for affected women, including bone fractures and infertility. what do the investigators propose? improve the diagnosis of women with fha by composing an assessment score, which could be used by women to improve the accuracy of diagnosing fha. the investigators designed a questionnaire based on literature search, which can be used to identify women with fha. a questionnaire-based study (on-line or in person) will be performed to identify risk of fha, in women referred to hospital with period loss.

a questionnaire was developed to be used by women with period loss to facilitate the diagnosis of women with fha. the development of the questionnaire was based on systematic literature review and comments from a small patient involvement group, as per national institute for health and care research (nihr) involve guidelines. participants will be recruited via distributing a patient information sheet, consent form and a questionnaire to all women referred with amenorrhea to the endocrinology or reproductive medicine clinics at imperial college healthcare nhs trust and/or participating nhs organisations. completion of the consent form and questionnaire is entirely dependent on each potential participant's choice. every woman taking part can complete the questionnaire before or after her appointment. all questionnaires will be anonymised with a unique study code, and handed back to the nhs clinician.

Eligibility criteria:
inclusion criteria: * any woman 18-58 years of age * secondary amenorrhea defined by either menstrual cycle interval persistently exceeding 45 days and/or those with period loss for 3 months or more exclusion criteria: * women who never had periods (primary amenorrhea).
virtual senior center

Conditions: Social Isolation in Older Adults; Quality of Life (QOL); Activities of Daily Living

Summary: in a 3-group trial with randomization and follow-up for 12 months, we will compare use of the vsc as well as health and quality of life outcomes among 650 older adults in st. louis who receive either: (1) home delivered meals and a grandpad; (2) home-delivered meals but no grandpad for 6 months; and (3) in person meals at senior center but no grandpad.

the aims of the study are: 1. recruit 650 older adults in st. louis into the study - 400 home-delivered meal recipients and 250 receiving in-person meals at senior centers. describe baseline differences between the two groups in use of senior center programming, technology access and use, and health and quality of life outcomes. 2. randomly assign the 400 home-delivered meal recipients to get a grandpad immediately (gp) or 6 months later (gp-6). compare the gp and gp-6 groups to in-person meal recipients (ip) on: (a) vsc engagement at 6- and 12-month follow-up; and (b) health and quality of life outcomes at 6- and 12-month follow-up. 3. examine longitudinal changes and hypothesized mediating pathways using 5 waves of data from baseline, 3-,6-,9- and 12-month follow-up. specifically: (a) in the gp-6 group only, compare vsc engagement, health and quality of life outcomes at 6-month follow-up (a period in which they did not have a grandpad) to 12-month follow-up (a period in which they did have a grandpad); (b) examine 12-month trends in grandpad and vsc engagement, health and quality of life outcomes within and across groups; and (c) test mediation of hypothesized explanatory variables from the study's conceptual framework to examine potential causal pathways for health and quality of life outcomes.

Eligibility criteria:
inclusion criteria: * current home-delivered meal client with aging ahead exclusion criteria: * under age 65

Keywords: digital access for older adults
the effect of breakfast with different macronutrient composition on pyy, ghrelin, glp-1,glucose level, vas for hunger, vas for satiety and ad libitum intake 4 hours after breakfast in obese women

Conditions: PYY; Ghrelin; Appetite; Gut Hormones; Obesity; Protein Consumption

Summary: gut hormones, such as pyy and ghrelin, are associated with appetite control and obesity. protein is thought to be the most satieting nutrient and could affect production of several gut hormones. this study's objective is to find the effect of breakfast with different protein composition on pyy, ghrelin, and ad libitum intake four hours after breakfast. the research methodology was used a clinical trial with 22 obese women participants. subjects were given three types of breakfast: low protein consumption (12.4% protein), medium protein (23.5% protein), and high protein (40,6% protein). pyy and ghrelin level were measured at 0, 15, 60, 120, and 180 minutes after breakfast. ad libitum meal was given four hours after breakfast and measured after.


Eligibility criteria:
inclusion criteria: * bmi 25-30 (obese) * with stable body weight within the last 6 months (body weight change less than 4 kg) * normal blood glucose level. exclusion criteria: * patients who never had breakfast * patients in weight loss program * patients consuming lipid-absorption inhibitor or appetite-suppressing drugs * patients that have had gastrointestinal tract resection.

Keywords: pyy ghrelin ad libitum intake high protein diet moderately protein diet low protein diet breakfast obesity
feasibility assessment of neurophysiological measurement in veterans with lbp

Conditions: Low Back Pain

Summary: this is study testing the feasibility of collecting neurophysiological measures of outcome related to body-based interventions for low back pain. the investigators will collect fmri and psychophysical data about pain sensitivity before and after the interventions. participants will be randomly assigned to either spinal manipulation or therapeutic touch groups. participants will attend two practice sessions prior to the first data collection. there will be two follow-up assessments.

participants will be enrolled from va pain clinical at the north florida/south george va medical center. the investigators will collect functional magnetic resonance imaging data of resting state and pain-related events (i.i. during thermal pain sensitivity testing, as well as psychophysical data to determine pain sensitivity. pain sensitivity will be measured using thermal and mechanical stimuli. these data will be collected before and after the interventions, in addition to two follow-up sessions after intervention. in addition, clinical measures of pain intensity in the low back, as well as trunk range of motion and strength will also be collected.

Eligibility criteria:
inclusion criteria: * complaints of current back pain that they rate at least 40 on a 101-point numeric rating scale * participants must able to understand written and spoken english exclusion criteria: * currently receiving treatment for lbp or have received smt for lbp in the past year * quebec task force on spinal disorders (qtfsd) to identify patients with pre-existing nerve root compression, spinal stenosis, or post-surgery * any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches) * any contraindication to mri
postoperative renal failure in cardiac surgery pmsf-pvc gradient study

Conditions: Scheduled Heart Surgery; Valve Replacement; Coronary Artery Bypass

Summary: acute renal failure is a frequent and severe postoperative complication of cardiac surgery performed under extracorporeal circulation. it is an independent risk factor for mortality and significantly increases the length of hospital stay. the origin of renal insufficiency after extracorporeal circulation is multifactorial (long duration of extracorporeal circulation, hemodynamic instability per and post-extracorporeal circulation, prolonged hypotension, transfusion ...). nevertheless, an entirely different pathophysiological mechanism, though not recent, is less often mentioned but shows renewed interest. this is the concept of renal venous congestion which may be responsible for impaired renal function in the absence of cardiac dysfunction. based on guyton's circulatory model, the investigators approach this systemic venous hypertension through the measurement of the pmsf-pvc gradient.


Eligibility criteria:
inclusion criteria: * age\> 18 years * subject having signed an informed consent * scheduled heart surgery: * valve replacement * coronary artery bypass exclusion criteria: * any urgent surgery or redux * severe preoperative chronic renal failure (stage iii) defined by gfr \<30ml / min * existence of rhythm disorders (permanent acfa) or serious cardiac conduction disorders, patients with pacemaker * preoperative alteration of left ventricular ejection fraction with lvef \<40% * major haemodynamic instability with refractory shock defined by dobutamine ≥10μg / kg / min and / or norepinephrine ≥ 1μg / kg / min and / or epinephrine ≥ 0.2μg / kg / min. * intra-aortic versus assisted pelvic balloon * contraindication to femoral arterial catheterization * subject under the protection of justice, subject under guardianship or under tutorship * impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)
treatment of keratoconus using collagen cross-linking

Conditions: Keratoconus

Summary: the purpose of this study is to determine the effectiveness of collagen cross-linking in the cornea in halting the progression and possibly partially reversing the effects of keratoconus. keratoconus is a progressive weakening in the cornea that causes irregular astigmatism and thinning of the cornea. the overall effect is reduction of vision, and in more advanced cases, scarring of the cornea that may lead to the need for corneal transplantation. cross-linking has been shown increase the rigidity of the cornea. the patients would be treated once and then followed over 24 months. .

the goal is for two groups of approximately 66 patients to be included in the study. one eye from the first group will undergo treatment, while the second group of age matched individuals will serve as a control. it will be a prospective, randomized, blinded study. each patient will be randomized at the beginning of enrollment in the study and will receive a randomization number. the following parameters will be followed: 1. best corrected spectacle acuity (bcsa) 2. the steepest keratometry measurement (kmax) as measured by computerized corneal topography 3. apical corneal thickness 4. corneal mechanical resistance. these measurements will be repeated at 1 month, 3 months, 6 months, 12, 18, and 24 months following treatment.

Eligibility criteria:
inclusion criteria: * no prior history of ocular surgery * treatment eye must have a maximum corneal power of between 47 d and 60 diopters * corneal thickness must be greater than 400 µ * absence of corneal scarring * patients must meet the diagnostic criteria for keratoconus, which include one or more of the following features: * high myopia * corneal ectasia as viewed by slit-lamp exam or measured by pachometry * vogt's striae * topographic findings of superior flattening and inferior steepening of the cornea * presence of fleischer ring exclusion criteria: * history of prior ocular surgery (history of contact lens use is not an exclusion criterion) * average corneal power \> 60 d * presence of corneal scarring * corneal thickness 400 µ or less * history of herpes simplex virus keratitis * history of uveitis * pre-existing glaucoma

Keywords: cornea keratoconus ectasia riboflavin collagen cross-linking